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This study will enroll up to 80 subjects with Chronic Post COVID-19 Syndrome. Subjects will receive four intravenous injections of either allogeneic HB-adMSC's or a placebo over 10 weeks with two follow-up visits and an end of study visit at week 26.
Active Product: HB- adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells - allogeneic) Dose: 200 million Route: Intravenous Regimen: Weeks 0, 2, 6, and 10. Placebo: Saline Solution 0.9% Dose: N/A Route: Intravenous Regimen: Weeks 0, 2, 6, and 10.Duration of administration 1 hour Laboratory Samples. Screening, Week 0, 6, and 26. Visits by Weeks Screening Week 0 - Infusion 1 Week 2 - Infusion 2 Week 6 - Infusion 3 Week 10 - Infusion 4 Week 14 - Follow Up 1 Week 20 - Follow Up 2 Week 26 - End of Study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Active Comparator | HB-ad MSC's allogeneic |
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| Placebo | Placebo Comparator | Sterile Normal Saline |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HB-adMSCs (allogeneic) | Biological | HB-adMSCs allogenic |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Extreme Fatigue (ANCOVA Model) | Clinically significant changes in Visual Analog Scale - Extreme fatigue. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure extreme fatigue has one end labeled "no fatigue" and the other end labeled "worst fatigue". The patient then marks a point on the line to indicate their current level of fatigue. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (fatigue). | Baseline to Weeks 26 |
| Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (ANCOVA Model) | Clinically significant changes in Visual Analog Scale - Brain fog. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure brain fog has one end labeled "no brain fog" and the other end labeled "worst brain fog". The patient then marks a point on the line to indicate their current level of brain fog. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (brain fog). | Baseline to Weeks 26 |
| Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (ANCOVA Model) | Clinically significant changes in Visual Analog Scale - Headache. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure Headache has one end labeled "no headache" and the other end labeled "worst headache". The patient then marks a point on the line to indicate their current level of Headache. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (headache). | Baseline to Weeks 26 |
| Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (ANCOVA Model) | Clinically significant changes in Visual Analog Scale - Sleep disturbances. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure sleep disturbance has one end labeled "no sleep disturbance" and the other end labeled "worst sleep disturbance". The patient then marks a point on the line to indicate their current level of sleep disturbance. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (sleep disturbance). |
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea at Rest (ANCOVA Model) | Clinically significant changes in Visual Analog Scale - Dyspnea at rest. Score ranges from 0 points (no dyspnea) to 10 points (maximum amount of dyspnea). | Baseline (Infusion 1) to Weeks 26 (End of Study) |
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Inclusion Criteria:
A study participant will be eligible for inclusion in this study only if all the following criteria apply:
1 Male and female participants 18 - 70 years of age.
2. Participants in the study have proof of Post COVID-19 Syndrome in their medical records.
3. Study participants must have been diagnosed with Chronic post-COVID-19 syndrome for at least twelve weeks before enrollment in the clinical trial.
4. The study participant is experiencing one or more neurological symptoms for at least 12 weeks, either continually or intermittently, with relapses not experienced pre-illness that interferes with regular daily activities. Symptoms must be new symptoms or dramatic worsening of preexisting symptoms, i.e., the subject didn't have symptoms and had not sought medical treatment for the symptoms before COVID-19, or the symptoms are dramatically worse (in severity and frequency). At least one symptom must have a severity of "5cm" on the neurological symptom VAS at screening. See the list of symptoms below:
Extreme fatigue: Feeling overtired with low energy and a strong desire to sleep.
Brain Fog: A diminished mental capacity marked by the inability to concentrate, think or reason clearly interferes with daily activities.
Headache: Sharp or dull reoccurring or intermittent that were not present pre-illness.
Sleep Issues: Any sleep disturbances in sleep quality that makes sleep seem inadequate or unrefreshing like insomnia or hypersomnia.
Loss of Taste/Smell: A diminished sense of taste or smell.
5. Study participants should be able to read, understand, and provide written consent.
6. Female study participants should not be pregnant or plan to become pregnant during study participation and six months after the last investigational product administration.
7. If their sexual partners can become pregnant, male participants should use a method of contraception during study participation and for six months after the last administration of the experimental drug. *
8. The study participant is able and willing to comply with the requirements of this clinical trial.
Exclusion Criteria:
A study participant will not be eligible for inclusion in this clinical trial if any of the following criteria apply:
The subject is unable to provide informed consent or to comply with study requirements.
A study participant has currently been diagnosed with active COVID-19 disease, defined as ongoing symptoms related to acute infection (such as fever or chills, cough, shortness of breath, or difficulty breathing, among other symptoms), and evidence of a positive RT-PCR SARS- CoV-2.
The subject is unwilling to agree to the use of acceptable methods of contraception * throughout the study and for six months after the last dose of the investigational product.
Pregnancy, lactation. Women of childbearing age who are not pregnant but do not take adequate contraceptive measures. *
The study participant has a history of addiction or dependency, or he or she is currently abusing or using substances.
Study participant has any active malignancy, including but not limited to evidence of cutaneous basal, squamous cell carcinoma, or melanoma.
The study participant has one or more significant concurrent medical conditions (verified by medical records), including the following:
Study participant has received any stem cell treatment within 12 months before the first dose of the investigational product other than stem cells produced by Hope Biosciences.
The study participant has received an experimental drug within 12 months before the first dose of the investigational product. (Except for COVID-19 vaccinations)
Study participant has a laboratory abnormality during screening, including the following:
The study participant has any known ongoing infection, including TB, CMV, EBV, HSV, VZV, hepatitis virus, toxoplasmosis, HIV, syphilis infections, hepatitis B surface antigen-positive, or hepatitis C PCR positivity.
The study participant is unlikely to complete the study or adhere to the study procedures.
The study participant has a previously diagnosed psychiatric condition that may affect self-assessments in the investigator's opinion.
Study participants with any systemic infection requiring treatment with antibiotics, antivirals, or antifungals within 30 days before the first dose of the investigational product.
Male study participants expect to donate sperm during the trial or within six months after the last dose. Female patients intend to donate eggs or have IVF treatment during the trial or within six months after the last dose.
Study participants who the Investigator determines to be unsuitable for study enrollment for other reasons, such as, but not limited to deep vein thrombosis (DVT), pulmonary embolus, those who have a prothrombotic condition, or who require persistent oxygen supplementation.
The subject has recently been diagnosed with an unstable Chronic obstructive pulmonary disease (COPD) as defined by patients who experience frequent or severe exacerbations and a faster decline in pulmonary function.
Subjects who have fatigue due to chronic kidney disease, iron deficiency anemia, B12 deficiency and other anemias will be excluded.
Any participant who has suicidal ideation at the screening visit will be excluded from this clinical trial.
Subjects with the following diseases must be excluded from participation in the trial.
chronic liver disease
pneumonia
history of chronic fatigue syndrome
subjects with fatigue symptoms due to fibromyalgia, arthritic disorders, inflammatory and rheumatological disorders
respiratory failure
emphysema
uncontrolled asthma
any subject requiring supplemental oxygen for any cause.
1. True sexual abstinence (abstaining from sexual activity during the entire period of risk).
2. Surgery (occlusion bilateral tubal ligation, vasectomized partner). 3. Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable patch, or intravaginal). 4. Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS). 5. Condoms.
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| Name | Affiliation | Role |
|---|---|---|
| Thanh Cheng, MD | Hope Biosciences Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hope Biosciences Research Foundation | Sugar Land | Texas | 77478 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | HB-adMSCs | HB-adMSCs (allogeneic): HB-adMSCs allogenic |
| FG001 | Placebo | Placebo: Placebo comarator |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | HB-adMSCs | HB-adMSCs (allogeneic) |
| BG001 | Placebo | Placebo comarator |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Extreme Fatigue (ANCOVA Model) | Clinically significant changes in Visual Analog Scale - Extreme fatigue. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure extreme fatigue has one end labeled "no fatigue" and the other end labeled "worst fatigue". The patient then marks a point on the line to indicate their current level of fatigue. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (fatigue). | Posted | Mean | Standard Error | score on a scale (10 points total) | Baseline to Weeks 26 |
|
Week 0 (Infusion 1) through Week 26 (End of Study)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HB-adMSCs | HB-adMSCs (allogeneic): HB-adMSCs allogenic | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ridhima Vij, PhD | Hope Biosciences Research Foundation | 346-900-0340 | 102 | ridhima@hopebio.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 5, 2022 | Oct 4, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 5, 2022 | Oct 4, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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Randomized Double-Blind
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Amber bags will be used to 'blind' the participant and investigator to which group the subject belongs in.
| Placebo | Other | Placebo comarator |
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| Baseline to Weeks 26 |
| Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (ANCOVA Model) | Clinically significant changes in Visual Analog Scale - Loss of taste. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure loss of taste has one end labeled "no loss of taste" and the other end labeled "worst loss of taste". The patient then marks a point on the line to indicate their current level of loss of taste. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (loss of taste). | Baseline to Weeks 26 |
| Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (ANCOVA Model) | Clinically significant changes in Visual Analog Scale - Loss of smell. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure loss of smell has one end labeled "no loss of smell" and the other end labeled "worst loss of smell". The patient then marks a point on the line to indicate their current level of loss of smell. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (loss of smell). | Baseline to Weeks 26 |
| Changes From Baseline in Visual Analog Scale of Neurological Symptoms - Extreme Fatigue (RMA Model) | Clinically significant changes in Visual Analog Scale. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure extreme fatigue has one end labeled "no fatigue" and the other end labeled "worst fatigue". The patient then marks a point on the line to indicate their current level of fatigue. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (fatigue). | Baseline to Week 26 |
| Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (RMA Model) | Clinically significant changes in Visual Analog Scale - Brain fog. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure brain fog has one end labeled "no brain fog" and the other end labeled "worst brain fog". The patient then marks a point on the line to indicate their current level of brain fog. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (brain fog). | Baseline to Week 26 |
| Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (RMA Model) | Clinically significant changes in Visual Analog Scale - Headache. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure Headache has one end labeled "no headache" and the other end labeled "worst headache". The patient then marks a point on the line to indicate their current level of Headache. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (headache). | Baseline to Week 26 |
| Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (RMA Model) | Clinically significant changes in Visual Analog Scale - Sleep Disturbances. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure sleep disturbance has one end labeled "no sleep disturbance" and the other end labeled "worst sleep disturbance". The patient then marks a point on the line to indicate their current level of sleep disturbance. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (sleep disturbance). | Baseline to Weeks 26 |
| Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (RMA Model) | Clinically significant changes in Visual Analog Scale - Loss of taste. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure loss of taste has one end labeled "no loss of taste" and the other end labeled "worst loss of taste". The patient then marks a point on the line to indicate their current level of loss of taste. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (loss of taste). | Baseline to Weeks 26 |
| Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (RMA Model) | Clinically significant changes in Visual Analog Scale - Loss of smell. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure loss of smell has one end labeled "no loss of smell" and the other end labeled "worst loss of smell". The patient then marks a point on the line to indicate their current level of loss of smell. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (loss of smell). | Baseline to Weeks 26 |
| Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Clinically significant changes in CBC values. | Baseline to Weeks 26 |
| Changes in Laboratory Values. - CBC. (% of WBC) | Clinically significant changes in CBC values. | Baseline to Weeks 26 |
| Changes in Laboratory Values. - CBC (pg) | Changes from baseline in CBC laboratory values with unit of pg. | Baseline (Week 0), Week 10, and End of Study (Week 26) |
| Changes in Laboratory Values. - CBC (g/dL) | Changes from baseline in CBC laboratory values with unit of g/dL. | Baseline (Week 0), Week 10, and End of Study (Week 26) |
| Changes in Laboratory Values. - CBC (fL) | Changes from baseline in CBC laboratory values with unit of fL. | Baseline (Week 0), Week 10, and End of Study (Week 26) |
| Changes in Laboratory Values. - CBC (x10^6 Cells/uL) | Changes from baseline in CBC laboratory values with unit of 10^6 cells/uL. | Baseline (Week 0), Week 10, and End of Study (Week 26) |
| Changes in Laboratory Values. - CBC (% Difference in Volume and Size of RBC) | Changes from baseline in CBC laboratory values with unit % Difference in Volume and Size of RBC | Baseline (Week 0), Week 10, and End of Study (Week 26) |
| Changes in Laboratory Values. - CBC (% of Total Blood Cell Count) | Changes from baseline in CBC laboratory values with unit of % of Total Blood Cell Count. | Baseline (Week 0), Week 10, and End of Study (Week 26) |
| Changes in Laboratory Values. - CMP (g/dL) | Clinically significant changes in CMP values. | Baseline (Week 0), Week 10, and End of Study (Week 26) |
| Changes in Laboratory Values. - Coagulation Panel. Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds | Clinically significant changes in Coagulation Panel values with units of Ratio: Prothrombin time (seconds) / Mean normal prothrombin time (seconds). | Baseline (Week 0), Week 10, and End of Study (Week 26) |
| Changes From Baseline in Vital Signs. - Respiratory Rate (Breaths Per Minute) | Clinically significant changes in Respiratory Rate (breaths per minute) | Baseline to Weeks 26 |
| Changes From Baseline in Vital Signs. - Heart Rate (Beats Per Minute) | Clinically significant changes in Heart Rate (beats per minute) | Baseline to Weeks 26 |
| Changes From Baseline in Vital Signs. - Body Temperature (Celsius) | Clinically significant changes in Body Temperature (Celsius) | Baseline to Week 10, End of Study at Weeks 26 |
| Changes in Vital Signs. - Blood Pressure (mmHg) | Clinically significant changes in Blood Pressure. | Baseline to Weeks 10, End of Study at Week 26 |
| Changes in Weight in kg. | Change from baseline in Weight in kg. | Baseline to Weeks 10, End of Study at Week 26 |
| Changes in Physical Examination Results. - Abdomen | Clinically significant changes in physical examination results - Abdomen body system | Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26 |
| Changes in Laboratory Values. - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL) | Changes from baseline in CMP laboratory values with units of Ratio: Albumin(g/dL) to Calc. Globulin(g/dL) | Baseline (Week 0), Week 10, and End of Study (Week 26) |
| Changes in Laboratory Values. - CMP (U/L) | Clinically significant changes in CMP values with units of U/L. | Baseline (Week 0), Week 10, and End of Study (Week 26) |
| Changes in Laboratory Values. - CMP (mg/dL) | Clinically significant changes in CMP values with units of mg/dL. | Baseline (Week 0), Week 10, and End of Study (Week 26) |
| Changes in Laboratory Values. - CMP (mEq/L) | Clinically significant changes in CMP values with units of mEq/L. | Baseline (Week 0), Week 10, and End of Study (Week 26) |
| Changes in Laboratory Values. - CMP (mL/Min/1.73m^2) | Clinically significant changes in CMP values with units of mL/min/1.73m^2. | Baseline (Week 0), Week 10, and End of Study (Week 26) |
| Changes in Laboratory Values. - CMP (Calc BUN mg/dL /Creat mg/dL Ratio) | Clinically significant changes in CMP values with units of Calc BUN mg/dL /Creat mg/dL Ratio | Baseline (Week 0), Week 10, and End of Study (Week 26) |
| Changes in Laboratory Values. - Coagulation Panel. (Seconds) | Clinically significant changes in Coagulation Panel values with units of seconds. | Baseline (Week 0), Week 10, and End of Study (Week 26) |
| Changes in Physical Examination Results. - Cardiovascular | Clinically significant changes in physical examination results - Cardiovascular body system | Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26 |
| Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | Clinically significant changes in physical examination results - Head, Eyes, Ears, Nose, and Throat body system | Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26 |
| Changes in Physical Examination Results. - Lymph Node | Clinically significant changes in physical examination results - Lymph Node | Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26 |
| Changes in Physical Examination Results. - Musculoskeletal | Clinically significant changes in physical examination results - Musculoskeletal | Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26 |
| Changes in Physical Examination Results. - Neurological | Clinically significant changes in physical examination results - Neurological | Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26 |
| Changes in Physical Examination Results. - Respiratory | Clinically significant changes in physical examination results - Respiratory | Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26 |
| Changes in Physical Examination Results. - Skin | Clinically significant changes in physical examination results - Skin. Patients are ranked as normal or abnormal per body system. | Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26 |
| Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea During Activity (ANCOVA Model) |
Clinically significant changes in Visual Analog Scale - Dyspnea during activity. Score ranges from 0 points (no dyspnea) to 10 points (maximum amount of dyspnea) |
| Baseline (Infusion 1) to Weeks 26 (End of Study) |
| Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Cough (ANCOVA Model) | Clinically significant changes in Visual Analog Scale - Cough. Score ranges from 0 points (no cough) to 10 points (maximum amount of cough). | Baseline (Infusion 1) to Weeks 26 (End of Study) |
| Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Body Aches (ANCOVA Model) | Clinically significant changes in Visual Analog Scale - Body aches. Score ranges from 0 points (no body aches) to 10 points (maximum amount of body aches). | Baseline (Infusion 1) to Weeks 26 (End of Study) |
| Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Joint Pain (ANCOVA Model) | Clinically significant changes in Visual Analog Scale - Joint Pain. Score ranges from 0 points (no pain) to 10 points (maximum amount of pain). | Baseline (Infusion 1) to Weeks 26 (End of Study) |
| Changes From Baseline in Subject's Energy - Fatigue Assessment Form (ANCOVA Model) | Clinically significant changes in Fatigue Assessment form. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest. | Baseline (Infusion 1) to Weeks 26 (End of Study) |
| Changes in Subject's Quality of Life - Short Form 36 Health Survey Questionnaire (General Health) | Short-form (36) Health Survey domain Average General Health; scored on a scale of 0-100; lower score equals more disability. | Baseline (Infusion 1) to Weeks 26 (End of Study) |
| Changes in Subject's Level of Depression - PHQ 9 Scale. | Clinically significant changes in PHQ (Patient health questionnaire) 9 scale. The PHQ-9 is a 9 question assessment with a total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression) [30]. | Baseline (Infusion 1) to Weeks 26 (End of Study) |
| Changes in Subject's Quality of Life - Short Form 36 Health Survey Questionnaire (Physical Functional Score) | Short-form (36) Health Survey domain Average Physical Functioning; scored on a scale of 0-100; lower score equals more disability. | Baseline (Infusion 1) to Weeks 26 (End of Study) |
| Total |
Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Height | Mean | Standard Deviation | centimeter |
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| Weight | Mean | Standard Deviation | kilograms |
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Placebo: Placebo comarator |
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| Primary | Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (ANCOVA Model) | Clinically significant changes in Visual Analog Scale - Brain fog. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure brain fog has one end labeled "no brain fog" and the other end labeled "worst brain fog". The patient then marks a point on the line to indicate their current level of brain fog. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (brain fog). | Posted | Mean | Standard Error | score on a scale (10 points total) | Baseline to Weeks 26 |
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| Primary | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (ANCOVA Model) | Clinically significant changes in Visual Analog Scale - Headache. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure Headache has one end labeled "no headache" and the other end labeled "worst headache". The patient then marks a point on the line to indicate their current level of Headache. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (headache). | Posted | Mean | Standard Error | score on a scale (10 points total) | Baseline to Weeks 26 |
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| Primary | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (ANCOVA Model) | Clinically significant changes in Visual Analog Scale - Sleep disturbances. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure sleep disturbance has one end labeled "no sleep disturbance" and the other end labeled "worst sleep disturbance". The patient then marks a point on the line to indicate their current level of sleep disturbance. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (sleep disturbance). | Posted | Mean | Standard Error | score on a scale (10 points total) | Baseline to Weeks 26 |
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| Primary | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (ANCOVA Model) | Clinically significant changes in Visual Analog Scale - Loss of taste. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure loss of taste has one end labeled "no loss of taste" and the other end labeled "worst loss of taste". The patient then marks a point on the line to indicate their current level of loss of taste. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (loss of taste). | Posted | Mean | Standard Error | score on a scale (10 points total) | Baseline to Weeks 26 |
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| Primary | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (ANCOVA Model) | Clinically significant changes in Visual Analog Scale - Loss of smell. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure loss of smell has one end labeled "no loss of smell" and the other end labeled "worst loss of smell". The patient then marks a point on the line to indicate their current level of loss of smell. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (loss of smell). | Posted | Mean | Standard Error | score on a scale (10 points total) | Baseline to Weeks 26 |
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| Primary | Changes From Baseline in Visual Analog Scale of Neurological Symptoms - Extreme Fatigue (RMA Model) | Clinically significant changes in Visual Analog Scale. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure extreme fatigue has one end labeled "no fatigue" and the other end labeled "worst fatigue". The patient then marks a point on the line to indicate their current level of fatigue. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (fatigue). | Posted | Mean | Standard Error | score on a scale (10 points total) | Baseline to Week 26 |
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| Primary | Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (RMA Model) | Clinically significant changes in Visual Analog Scale - Brain fog. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure brain fog has one end labeled "no brain fog" and the other end labeled "worst brain fog". The patient then marks a point on the line to indicate their current level of brain fog. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (brain fog). | Posted | Mean | Standard Error | score on a scale (10 points total) | Baseline to Week 26 |
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|
|
| Primary | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (RMA Model) | Clinically significant changes in Visual Analog Scale - Headache. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure Headache has one end labeled "no headache" and the other end labeled "worst headache". The patient then marks a point on the line to indicate their current level of Headache. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (headache). | Posted | Mean | Standard Error | score on a scale (10 points total) | Baseline to Week 26 |
|
|
|
|
| Primary | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (RMA Model) | Clinically significant changes in Visual Analog Scale - Sleep Disturbances. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure sleep disturbance has one end labeled "no sleep disturbance" and the other end labeled "worst sleep disturbance". The patient then marks a point on the line to indicate their current level of sleep disturbance. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (sleep disturbance). | Posted | Mean | Standard Error | score on a scale (10 points total) | Baseline to Weeks 26 |
|
|
|
|
| Primary | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (RMA Model) | Clinically significant changes in Visual Analog Scale - Loss of taste. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure loss of taste has one end labeled "no loss of taste" and the other end labeled "worst loss of taste". The patient then marks a point on the line to indicate their current level of loss of taste. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (loss of taste). | Posted | Mean | Standard Error | score on a scale (10 points total) | Baseline to Weeks 26 |
|
|
|
|
| Primary | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (RMA Model) | Clinically significant changes in Visual Analog Scale - Loss of smell. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure loss of smell has one end labeled "no loss of smell" and the other end labeled "worst loss of smell". The patient then marks a point on the line to indicate their current level of loss of smell. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (loss of smell). | Posted | Mean | Standard Error | score on a scale (10 points total) | Baseline to Weeks 26 |
|
|
|
|
| Primary | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Clinically significant changes in CBC values. | Posted | Mean | Standard Error | x10^3 cells/uL | Baseline to Weeks 26 |
|
|
|
| Primary | Changes in Laboratory Values. - CBC. (% of WBC) | Clinically significant changes in CBC values. | Posted | Mean | Standard Error | % of WBC | Baseline to Weeks 26 |
|
|
|
| Primary | Changes in Laboratory Values. - CBC (pg) | Changes from baseline in CBC laboratory values with unit of pg. | Posted | Mean | Standard Error | pg | Baseline (Week 0), Week 10, and End of Study (Week 26) |
|
|
|
| Primary | Changes in Laboratory Values. - CBC (g/dL) | Changes from baseline in CBC laboratory values with unit of g/dL. | Posted | Mean | Standard Error | g/dL | Baseline (Week 0), Week 10, and End of Study (Week 26) |
|
|
|
| Primary | Changes in Laboratory Values. - CBC (fL) | Changes from baseline in CBC laboratory values with unit of fL. | Posted | Mean | Standard Error | fL | Baseline (Week 0), Week 10, and End of Study (Week 26) |
|
|
|
| Primary | Changes in Laboratory Values. - CBC (x10^6 Cells/uL) | Changes from baseline in CBC laboratory values with unit of 10^6 cells/uL. | Posted | Mean | Standard Error | 10^6 cells/uL | Baseline (Week 0), Week 10, and End of Study (Week 26) |
|
|
|
| Primary | Changes in Laboratory Values. - CBC (% Difference in Volume and Size of RBC) | Changes from baseline in CBC laboratory values with unit % Difference in Volume and Size of RBC | Posted | Mean | Standard Error | % difference in volume and size of RBC | Baseline (Week 0), Week 10, and End of Study (Week 26) |
|
|
|
| Primary | Changes in Laboratory Values. - CBC (% of Total Blood Cell Count) | Changes from baseline in CBC laboratory values with unit of % of Total Blood Cell Count. | Posted | Mean | Standard Error | % of Total Blood Cell Count | Baseline (Week 0), Week 10, and End of Study (Week 26) |
|
|
|
| Primary | Changes in Laboratory Values. - CMP (g/dL) | Clinically significant changes in CMP values. | Posted | Mean | Standard Error | g/dL | Baseline (Week 0), Week 10, and End of Study (Week 26) |
|
|
|
| Primary | Changes in Laboratory Values. - Coagulation Panel. Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds | Clinically significant changes in Coagulation Panel values with units of Ratio: Prothrombin time (seconds) / Mean normal prothrombin time (seconds). | Posted | Mean | Standard Error | Ratio | Baseline (Week 0), Week 10, and End of Study (Week 26) |
|
|
|
| Primary | Changes From Baseline in Vital Signs. - Respiratory Rate (Breaths Per Minute) | Clinically significant changes in Respiratory Rate (breaths per minute) | Posted | Mean | Standard Error | breaths/min | Baseline to Weeks 26 |
|
|
|
| Primary | Changes From Baseline in Vital Signs. - Heart Rate (Beats Per Minute) | Clinically significant changes in Heart Rate (beats per minute) | Posted | Mean | Standard Error | beats per minute | Baseline to Weeks 26 |
|
|
|
| Primary | Changes From Baseline in Vital Signs. - Body Temperature (Celsius) | Clinically significant changes in Body Temperature (Celsius) | Posted | Mean | Standard Error | degrees Celsius | Baseline to Week 10, End of Study at Weeks 26 |
|
|
|
| Primary | Changes in Vital Signs. - Blood Pressure (mmHg) | Clinically significant changes in Blood Pressure. | Posted | Mean | Standard Error | mmHg | Baseline to Weeks 10, End of Study at Week 26 |
|
|
|
| Primary | Changes in Weight in kg. | Change from baseline in Weight in kg. | Posted | Mean | Standard Error | kg | Baseline to Weeks 10, End of Study at Week 26 |
|
|
|
| Primary | Changes in Physical Examination Results. - Abdomen | Clinically significant changes in physical examination results - Abdomen body system | Posted | Count of Participants | Participants | Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26 |
|
|
|
| Primary | Changes in Laboratory Values. - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL) | Changes from baseline in CMP laboratory values with units of Ratio: Albumin(g/dL) to Calc. Globulin(g/dL) | Posted | Mean | Standard Error | Ratio | Baseline (Week 0), Week 10, and End of Study (Week 26) |
|
|
|
| Primary | Changes in Laboratory Values. - CMP (U/L) | Clinically significant changes in CMP values with units of U/L. | Posted | Mean | Standard Error | U/L | Baseline (Week 0), Week 10, and End of Study (Week 26) |
|
|
|
| Primary | Changes in Laboratory Values. - CMP (mg/dL) | Clinically significant changes in CMP values with units of mg/dL. | Posted | Mean | Standard Error | mg/dL | Baseline (Week 0), Week 10, and End of Study (Week 26) |
|
|
|
| Primary | Changes in Laboratory Values. - CMP (mEq/L) | Clinically significant changes in CMP values with units of mEq/L. | Posted | Mean | Standard Error | mEq/L | Baseline (Week 0), Week 10, and End of Study (Week 26) |
|
|
|
| Primary | Changes in Laboratory Values. - CMP (mL/Min/1.73m^2) | Clinically significant changes in CMP values with units of mL/min/1.73m^2. | Posted | Mean | Standard Error | mL/min/1.73m^2 | Baseline (Week 0), Week 10, and End of Study (Week 26) |
|
|
|
| Primary | Changes in Laboratory Values. - CMP (Calc BUN mg/dL /Creat mg/dL Ratio) | Clinically significant changes in CMP values with units of Calc BUN mg/dL /Creat mg/dL Ratio | Posted | Mean | Standard Error | Ratio | Baseline (Week 0), Week 10, and End of Study (Week 26) |
|
|
|
| Primary | Changes in Laboratory Values. - Coagulation Panel. (Seconds) | Clinically significant changes in Coagulation Panel values with units of seconds. | Posted | Mean | Standard Error | seconds | Baseline (Week 0), Week 10, and End of Study (Week 26) |
|
|
|
| Primary | Changes in Physical Examination Results. - Cardiovascular | Clinically significant changes in physical examination results - Cardiovascular body system | Posted | Count of Participants | Participants | Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26 |
|
|
|
| Primary | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | Clinically significant changes in physical examination results - Head, Eyes, Ears, Nose, and Throat body system | Posted | Count of Participants | Participants | Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26 |
|
|
|
| Primary | Changes in Physical Examination Results. - Lymph Node | Clinically significant changes in physical examination results - Lymph Node | Posted | Count of Participants | Participants | Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26 |
|
|
|
| Primary | Changes in Physical Examination Results. - Musculoskeletal | Clinically significant changes in physical examination results - Musculoskeletal | Posted | Count of Participants | Participants | Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26 |
|
|
|
| Primary | Changes in Physical Examination Results. - Neurological | Clinically significant changes in physical examination results - Neurological | Posted | Count of Participants | Participants | No | Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26 |
|
|
|
| Primary | Changes in Physical Examination Results. - Respiratory | Clinically significant changes in physical examination results - Respiratory | Posted | Count of Participants | Participants | Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26 |
|
|
|
| Primary | Changes in Physical Examination Results. - Skin | Clinically significant changes in physical examination results - Skin. Patients are ranked as normal or abnormal per body system. | Posted | Count of Participants | Participants | Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26 |
|
|
|
| Secondary | Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea at Rest (ANCOVA Model) | Clinically significant changes in Visual Analog Scale - Dyspnea at rest. Score ranges from 0 points (no dyspnea) to 10 points (maximum amount of dyspnea). | Posted | Mean | Standard Error | score on a scale (10 points total) | Baseline (Infusion 1) to Weeks 26 (End of Study) |
|
|
|
|
| Secondary | Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea During Activity (ANCOVA Model) | Clinically significant changes in Visual Analog Scale - Dyspnea during activity. Score ranges from 0 points (no dyspnea) to 10 points (maximum amount of dyspnea) | Posted | Mean | Standard Error | score on a scale (10 points total) | Baseline (Infusion 1) to Weeks 26 (End of Study) |
|
|
|
|
| Secondary | Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Cough (ANCOVA Model) | Clinically significant changes in Visual Analog Scale - Cough. Score ranges from 0 points (no cough) to 10 points (maximum amount of cough). | Posted | Mean | Standard Error | score on a scale (10 points total) | Baseline (Infusion 1) to Weeks 26 (End of Study) |
|
|
|
|
| Secondary | Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Body Aches (ANCOVA Model) | Clinically significant changes in Visual Analog Scale - Body aches. Score ranges from 0 points (no body aches) to 10 points (maximum amount of body aches). | Posted | Mean | Standard Error | score on a scale (10 points total) | Baseline (Infusion 1) to Weeks 26 (End of Study) |
|
|
|
|
| Secondary | Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Joint Pain (ANCOVA Model) | Clinically significant changes in Visual Analog Scale - Joint Pain. Score ranges from 0 points (no pain) to 10 points (maximum amount of pain). | Posted | Mean | Standard Error | score on a scale (10 points total) | Baseline (Infusion 1) to Weeks 26 (End of Study) |
|
|
|
|
| Secondary | Changes From Baseline in Subject's Energy - Fatigue Assessment Form (ANCOVA Model) | Clinically significant changes in Fatigue Assessment form. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest. | Posted | Mean | Standard Error | score on a scale (50 points total) | Baseline (Infusion 1) to Weeks 26 (End of Study) |
|
|
|
|
| Secondary | Changes in Subject's Quality of Life - Short Form 36 Health Survey Questionnaire (General Health) | Short-form (36) Health Survey domain Average General Health; scored on a scale of 0-100; lower score equals more disability. | Posted | Mean | Standard Error | score on a scale (100 points total) | Baseline (Infusion 1) to Weeks 26 (End of Study) |
|
|
|
|
| Secondary | Changes in Subject's Level of Depression - PHQ 9 Scale. | Clinically significant changes in PHQ (Patient health questionnaire) 9 scale. The PHQ-9 is a 9 question assessment with a total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression) [30]. | Posted | Mean | Standard Error | score on a scale (27 points total) | Baseline (Infusion 1) to Weeks 26 (End of Study) |
|
|
|
|
| Secondary | Changes in Subject's Quality of Life - Short Form 36 Health Survey Questionnaire (Physical Functional Score) | Short-form (36) Health Survey domain Average Physical Functioning; scored on a scale of 0-100; lower score equals more disability. | Posted | Mean | Standard Error | score on a scale (100 points total) | Baseline (Infusion 1) to Weeks 26 (End of Study) |
|
|
|
|
| 39 |
| 0 |
| 39 |
| 34 |
| 39 |
| EG001 | Placebo | Placebo: Placebo comarator | 0 | 40 | 0 | 40 | 28 | 40 |
| Influenza like illness | General disorders | Non-systematic Assessment |
|
| Chills | General disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| Malaise | General disorders | Non-systematic Assessment |
|
| Asthenia | General disorders | Non-systematic Assessment |
|
| Feeling abnormal | General disorders | Non-systematic Assessment |
|
| Feeling hot | General disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Brain Fog | Nervous system disorders | Non-systematic Assessment |
|
| Cognitive Disorder | Nervous system disorders | Non-systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | Non-systematic Assessment |
|
| Ageusia | Nervous system disorders | Non-systematic Assessment |
|
| Anosmia | Nervous system disorders | Non-systematic Assessment |
|
| Coordination abnormal | Nervous system disorders | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | Non-systematic Assessment |
|
| Multiple Sclerosis | Nervous system disorders | Non-systematic Assessment |
|
| Muscle contractions involuntarily | Nervous system disorders | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | Non-systematic Assessment |
|
| Paresthesia | Nervous system disorders | Non-systematic Assessment |
|
| Parkinsonism | Nervous system disorders | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | Non-systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | Non-systematic Assessment |
|
| Epididymitis | Infections and infestations | Non-systematic Assessment |
|
| Genital herpes simplex | Infections and infestations | Non-systematic Assessment |
|
| Genital infection male | Infections and infestations | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | Non-systematic Assessment |
|
| Infected bite | Infections and infestations | Non-systematic Assessment |
|
| Infectious mononucleosis | Infections and infestations | Non-systematic Assessment |
|
| Lyme disease | Infections and infestations | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | Non-systematic Assessment |
|
| Post-acute COVID-19 syndrome | Infections and infestations | Non-systematic Assessment |
|
| Suspected COVID-19 | Infections and infestations | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhoea | Infections and infestations | Non-systematic Assessment |
|
| Dyspepsia | Infections and infestations | Non-systematic Assessment |
|
| Gastrointestinal disorder | Infections and infestations | Non-systematic Assessment |
|
| Paraesthesia oral | Infections and infestations | Non-systematic Assessment |
|
| Toothache | Infections and infestations | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Artificial crown procedure | Surgical and medical procedures | Non-systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | Non-systematic Assessment |
|
| Endodontic procedure | Surgical and medical procedures | Non-systematic Assessment |
|
| Hip surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| Mole excision | Surgical and medical procedures | Non-systematic Assessment |
|
| Oral surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| Tongue tie operation | Surgical and medical procedures | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | Non-systematic Assessment |
|
| Rheumatoid factor positive | Investigations | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Sensitive skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Eye movement disorder | Eye disorders | Non-systematic Assessment |
|
| Lacrimation increased | Eye disorders | Non-systematic Assessment |
|
| Vitreous floaters | Eye disorders | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Exposure to toxic agent | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Flushing | Vascular disorders | Non-systematic Assessment |
|
| Peripheral ischaemia | Vascular disorders | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | Non-systematic Assessment |
|
| Glucose tolerance impaired | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Breast tenderness | Reproductive system and breast disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Infusion 4 (Week 10) |
|
| EOS (Week 26) |
|
| Infusion 4 (Week 10) |
|
| End of Study (Week 26) |
|
| Infusion 4 (Week 10) |
|
| End Of Study (Week 26) |
|
| Infusion 4 (Week 10) |
|
| End of Study (Week 26) |
|
| Infusion 4 (Week 10) |
|
| End of Study (Week 26) |
|
| Infusion 4 (Week 10) |
|
| End Of Study (Week 26) |
|
| Absolute Basophils End of Study (Week 26) |
|
| Absolute Eosinophils Baseline/Infusion 1 (Week 0) |
|
| Absolute Eosinophils Infusion 4 (Week 10) |
|
| Absolute Eosinophils End of Study (Week 26) |
|
| Absolute Lymphocytes Baseline/Infusion 1 (Week 0) |
|
| Absolute Lymphocytes Infusion 4 (Week 10) |
|
| Absolute Lymphocytes End of Study (Week 26) |
|
| Absolute Monocytes Baseline/Infusion 1 (Week 0) |
|
| Absolute Monocytes Infusion 4 (Week 10) |
|
| Absolute Monocytes End of Study (Week 26) |
|
| Absolute Neutrophils Baseline/Infusion 1 (Week 0) |
|
| Absolute Neutrophils Infusion 4 (Week 10) |
|
| Absolute Neutrophils End of Study (Week 26) |
|
| Platelet Baseline/Infusion 1 (Week 0) |
|
| Platelet Infusion 4 (Week 10) |
|
| Platelet End of Study (Week 26) |
|
| WBC Baseline/Infusion 1 (Week 0) |
|
| WBC Infusion 4 (Week 10) |
|
| WBC End of Study (Week 26) |
|
| Basophils End of Study (Week 26) |
|
| Eosinophils Baseline/Infusion 1 (Week 0) |
|
| Eosinophils Infusion 4 (Week 10) |
|
| Eosinophils End of Study (Week 26) |
|
| Lymphocytes Baseline/Infusion 1 (Week 0) |
|
| Lymphocytes Infusion 4 (Week 10) |
|
| Lymphocytes End of Study (Week 26) |
|
| Monocytes Baseline/Infusion 1 (Week 0) |
|
| Monocytes Infusion 4 (Week 10) |
|
| Monocytes End of Study (Week 26) |
|
| Neutrophils Baseline/Infusion 1 (Week 0) |
|
| Neutrophils Infusion 4 (Week 10) |
|
| Neutrophils End of Study (Week 26) |
|
| MCH End of Study (Week 26) |
|
| MCHC End of Study (Week 26) |
|
| Hemoglobin Baseline/Infusion 1 (Week 0) |
|
| Hemoglobin Infusion 4 (Week 10) |
|
| Hemoglobin End of Study (Week 26) |
|
| MCV End of Study (Week 26) |
|
| RBC End of Study (Week 26) |
|
| RDW End of Study (Week 26) |
|
| Hematocrit End of Study (Week 26) |
|
| Albumin End of Study (Week 26) |
|
| Calc Globulin Baseline/Infusion 1 (Week 0) |
|
| Calc Globulin Infusion 4 (Week 10) |
|
| Calc Globulin End of Study (Week 26) |
|
| Protein Baseline/Infusion 1 (Week 0) |
|
| Protein Infusion 4 (Week 10) |
|
| Protein End of Study (Week 26) |
|
| INR End of Study (Week 26) |
|
| Infusion 3 (Week 6) |
|
| Infusion 4 (Week 10) |
|
| End of Study (Week 26) |
|
| Infusion 3 (Week 6) |
|
| Infusion 4 (Week 10) |
|
| End of Study (Week 26) |
|
| Infusion 3 (Week 6) |
|
| Infusion 4 (Week 10) |
|
| End of Study (Week 26) |
|
| Systolic Infusion 3 (Week 6) |
|
| Systolic Infusion 4 (Week 10) |
|
| Systolic End of Study (Week 26) |
|
| Diastolic Baseline/Infusion 1 (Week 0) |
|
| Diastolic Infusion 2 (Week 2) |
|
| Diastolic Infusion 3 (Week 6) |
|
| Diastolic Infusion 4 (Week 10) |
|
| Diastolic End of Study (Week 26) |
|
| Infusion 3 (Week 6) |
|
| Infusion 4 (Week 10) |
|
| End of Study (Week 26) |
|
| Not Examined (No Longer In Study) |
|
| Infusion 2 (Week 2) |
|
| Infusion 3 (Week 6) |
|
| Infusion 4 (Week 10) |
|
| End of Study (Week 26) |
|
| Calc A/G Ratio End of Study (Week 26) |
|
| Alkaline Phosphatase End of Study (Week 26) |
|
| Alanine aminotransferase Baseline/Infusion 1 (Week 0) |
|
| Alanine aminotransferase Infusion 4 (Week 10) |
|
| Alanine aminotransferase End of Study (Week 26) |
|
| Aspartate Aminotransferase Baseline/Infusion 1 (Week 0) |
|
| Aspartate Aminotransferase Infusion 4 (Week 10) |
|
| Aspartate Aminotransferase End of Study (Week 26) |
|
| Bilirubin End of Study (Week 26) |
|
| Calcium Baseline/Infusion 1 (Week 0) |
|
| Calcium Infusion 4 (Week 10) |
|
| Calcium End of Study (Week 26) |
|
| Creatinine Baseline/Infusion 1 (Week 0) |
|
| Creatinine Infusion 4 (Week 10) |
|
| Creatinine End of Study (Week 26) |
|
| Glucose Baseline/Infusion 1 (Week 0) |
|
| Glucose Infusion 4 (Week 10) |
|
| Glucose End of Study (Week 26) |
|
| Blood Urea Nitrogen Baseline/Infusion 1 (Week 0) |
|
| Blood Urea Nitrogen Infusion 4 (Week 10) |
|
| Blood Urea Nitrogen End of Study (Week 26) |
|
| Chloride End of Study (Week 26) |
|
| Carbon Dioxide Baseline/Infusion 1 (Week 0) |
|
| Carbon Dioxide Infusion 4 (Week 10) |
|
| Carbon Dioxide End of Study (Week 26) |
|
| Potassium Baseline/Infusion 1 (Week 0) |
|
| Potassium Infusion 4 (Week 10) |
|
| Potassium End of Study (Week 26) |
|
| Sodium Baseline/Infusion 1 (Week 0) |
|
| Sodium Infusion 4 (Week 10) |
|
| Sodium End of Study (Week 26) |
|
| Estimated Glomerular Filtration Rate End of Study (Week 26) |
|
| Calc BUN/Creat End of Study (Week 26) |
|
| Prothrombin Time End of Study (Week 26) |
|
| PTT Baseline/Infusion 1 (Week 0) |
|
| PTT Infusion 4 (Week 10) |
|
| PTT End of Study (Week 26) |
|
| Not Examined (No Longer In Study) |
|
| Infusion 2 (Week 2) |
|
| Infusion 3 (Week 6) |
|
| Infusion 4 (Week 10) |
|
| End of Study (Week 26) |
|
| Not Examined (No Longer In Study) |
|
| Infusion 2 (Week 2) |
|
| Infusion 3 (Week 6) |
|
| Infusion 4 (Week 10) |
|
| End of Study (Week 26) |
|
| Not Examined (No Longer In Study) |
|
| Infusion 2 (Week 2) |
|
| Infusion 3 (Week 6) |
|
| Infusion 4 (Week 10) |
|
| End of Study (Week 26) |
|
| Not Examined (No Longer In Study) |
|
| Infusion 2 (Week 2) |
|
| Infusion 3 (Week 6) |
|
| Infusion 4 (Week 10) |
|
| End of Study (Week 26) |
|
| Not Examined (No Longer In Study) |
|
| Infusion 2 (Week 2) |
|
| Infusion 3 (Week 6) |
|
| Infusion 4 (Week 10) |
|
| End of Study (Week 26) |
|
| Not Examined (No Longer In Study) |
|
| Infusion 2 (Week 2) |
|
| Infusion 3 (Week 6) |
|
| Infusion 4 (Week 10) |
|
| End of Study (Week 26) |
|
| Not Examined (No Longer In Study) |
|
| Infusion 2 (Week 2) |
|
| Infusion 3 (Week 6) |
|
| Infusion 4 (Week 10) |
|
| End of Study (Week 26) |
|